Global Trial Manager

Role Overview: As a Global Trial Manager, Clinical Operations at Sun Pharma, you will play a crucial role in the clinical development team based in Mumbai. Reporting to the Global Trial Leader, Clinical Operations, you will be responsible for assisting in the management of Sun Pharmaceuticals clinical trials globally, regionally, or at the complex local level. Your primary focus will be on overseeing the end-to-end clinical trial management process, including start-up, execution, close-out, and finalization of study reports. Your contributions will be essential in ensuring that all project tasks and timelines are on track. Key Responsibilities: - Oversight of CRO / other vendors and study management, including pre-site selection, site initiation, interim close-out, co-monitoring visits, and ensuring compliance with protocol and regulatory requirements - Assisting in the management of CROs and vendors to meet project requirements, and ensuring effective communication and monitoring of monitoring activities, data flow, and data validation - Evaluating and monitoring project progress and resources to ensure projects are on time and within budget - Reviewing operational aspects of trial activity and clinical protocols, providing oversight for trial implementation activities - Utilizing systems and business technologies to document and track study and user progress - Assisting in the review of clinical protocols, amendments, informed consents, CRF/source document design, protocol-specific training documentation, administrative letters, etc. - Performing regular reviews of data according to data review/monitoring guidelines and working with QA for CAPA documentation and resolution - Forecasting IP requirement during the study, preparing IP requisition, obtaining approval for clinical trial budget, and assisting in overall project planning and execution for clinical protocols - Collaborating with cross-functional teams, coordinating with Medical monitor, Regulatory Affairs, supply chain, statistics, Data management, QA and QC, CRO, vendors, etc. - Providing administrative support around meeting management, assembly of presentations for Investigator meeting and CRO/vendor kick-off meetings as required - Interacting with various internal and external teams to facilitate successful project completion - Demonstrating strong problem-solving and decision-making capabilities, staying current with industry trends, and building strong relationships with internal teams and external partners - Contributing to a team culture that promotes continuous improvement, ownership, professional growth, and inclusion Qualifications: - Minimum 6 years of clinical study management experience with at least 2 years of direct multinational study management experience - 2+ years of dermatology experience - Ability to manage delegated aspects of assigned clinical trials, CROs, and Clinical Study vendors - Bachelors level degree in life sciences, pharmacy, or nursing - Robust understanding of ICH/GCP and knowledge of regulatory requirements - Proficiency in MS Office including Word, Excel, PowerPoint, and other applications - Strong clinical study/project management skills - Outstanding communication skills, both verbal and written - Ability to work independently, prioritize duties, and understand Electronic Data capture (EDC), CDMS, IRT, etc. Please note that the above job description provides an overview of the role and responsibilities and is not an exhaustive list. The employer reserves the right to modify duties and responsibilities as needed. ,